Catheter insertion sterilization

• US 8,933,416 B2
• Filed: 05/11/2010
• Issued: 01/13/2015
• Est. Priority Date: 05/11/2009
• Status: Active Grant

• Current Assignee: Regents of The University of Minnesota (University of Minnesota)
• Original Assignee: Regents of The University of Minnesota (University of Minnesota)
• Inventors: Arcand, Benjamin, Hale, Joseph E., Murdeshwar, Nikhil, Rolfes, Bryan
• Primary Examiner(s): Johnston, Phillip A
• Assistant Examiner(s): LUCK, SEAN M
• Application Number:
  US13/319,875
• Publication Number:
  US 20120161032A1
• Time in Patent Office: 1,708 Days
• Field of Search: 250/454.11
• US Class Current: 250/455.11
• CPC Class Codes: A61L 2/0047 Ultraviolet radiation
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• CPC Class Codes: A61L 2202/11 Apparatus for generating biocidal substances, e.g. vaporisers, UV lamps
• CPC Class Codes: A61L 2202/14 Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61M 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 2039/0279 for introducing medical instruments into the body, e.g. endoscope, surgical tools
• CPC Class Codes: A61M 2039/0285 with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body
• CPC Class Codes: Y10T 29/49002 Electrical device making
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A device includes a sheath having a lumen defined by a wall. The wall has an outer surface that is configured to emit ultraviolet light in a direction substantially normal to the wall. The lumen has a distal end configured for percutaneous placement. The lumen has a proximal end configured to receive a catheter.

Claims

1. An apparatus for sterilizing one or both of a medical device and bodily tissue adjacent to the medical device, comprising:

a cylindrical sheath, extending from a sheath proximal end to a sheath distal end, including a sheath wall defining a sheath lumen, the sheath wall and the sheath lumen capable of receiving and transmitting a sterilizing light, wherein the sheath wall includes at least one channel comprising a longitudinal portion and a transverse portion, extending in a direction transverse to the longitudinal portion, the transverse portion including a port formed in an inner surface of the sheath wall, adjacent the sheath lumen, or an outer surface of the sheath wall;

a housing, surrounding the sheath proximal end, including a housing outer wall and a housing inner wall, the housing outer wall and housing inner wall defining a housing chamber there between, the housing inner wall defining a housing lumen, wherein the housing lumen and the sheath lumens are collinear and configured to receive a portion of the medical device; and

a sterilizing assembly including a light source electrically coupled to a battery, the light source and the battery located within the housing chamber.

2. The apparatus of claim 1, wherein the at least one channel includes a reflector to direct light to the port.

3. The apparatus of claim 1, wherein the at least one channel includes air, a light conductive polymer, a light conductive gas, or a light conductive fluid.

4. The apparatus of claim 1, wherein the sheath wall comprises an outer surface and an inner surface, at least one of the outer surface and the inner surface includes a raised or embossed pattern formed therein and configured to disperse light in a dispersion pattern corresponding to the raised or embossed pattern.

5. The apparatus of claim 1, wherein the sheath wall includes an outer surface and an inner surface, at least one of the outer surface and the inner surface includes a plurality of distribution channels formed therein, the plurality of distribution channels configured to circumferentially disperse light.

6. A method of manufacturing a sterilization apparatus, comprising:

forming or obtaining a cylindrical sheath extending from a proximal end to a distal end, including forming or obtaining a sheath wall configured to receive and transmit a sterilizing light and defining a sheath lumen, the sheath wall including at least one channel comprising a longitudinal portion and a transverse portion, extending in a direction transverse to the longitudinal portion, the transverse portion including a port formed in an inner surface of the sheath wall, adjacent the sheath lumen, or an outer surface of the sheath wall;

forming or obtaining an integrated, stand-alone illumination assembly comprising a housing, including a housing chamber and a housing lumen, and a sterilization assembly disposed in the housing chamber, the sterilization assembly including a light source electrically coupled to a battery; and

coupling the illumination assembly to the proximal end of the sheath, including aligning the sheath lumen and the housing lumen such that the sheath lumen and the housing lumen are collinear and configured to receive a portion of a medical device.

7. The method of claim 6, wherein forming the sheath includes forming at least one channel within the sheath wall, the at least one channel including air, a light conductive gas, a light conductive fluid, or a light conductive material other than a fiber optic cable.

8. The method of claim 6, wherein forming the sheath includes forming a polymer to simultaneously transmit light in a direction inward, toward the sheath lumen, and outward, away from the sheath lumen.

9. A method for sterilizing a medical device and a bodily tissue adjacent to the medical device, comprising:

providing or obtaining a cylindrical sheath having a sheath proximal end and a sheath distal end, and including a wall configured to receive and transmit a sterilizing light and defining a sheath lumen, the sheath wall including at least one channel comprising a longitudinal portion and a transverse portion, extending in a direction transverse to the longitudinal portion, the transverse portion including a port formed in an inner surface of the sheath wall, adjacent the sheath lumen, or outer surface of the sheath wall;

coupling an illumination assembly to the sheath proximal end, the illumination assembly comprising a housing, including a housing chamber and a housing lumen, and a sterilizing light source electrically coupled to a battery and disposed within the housing chamber, wherein the housing lumen is collinear with the sheath lumen when the housing illumination assembly is coupled to the sheath proximal end;

receiving a portion of a medical device within the housing lumen and within at least a portion of the sheath lumen; and

transmitting a sterilizing light from the sterilizing light source through the wall in a direction substantially normal to the wall.

10. The method of claim 9, wherein the step of receiving includes advancing the medical device through the sheath lumen from the sheath proximal end to the sheath distal end and into a bodily tissue or a bodily orifice or cavity.

11. A method for sterilizing a medical device and a bodily tissue adjacent to the medical device, comprising:

providing or obtaining a cylindrical sheath having a sheath proximal end and a sheath distal end, and including a wall configured to receive and transmit a sterilizing light and defining a sheath lumen, the sheath wall including at least one channel comprising a longitudinal portion and a transverse portion, extending in a direction transverse to the longitudinal portion, the transverse portion including a port formed in an inner surface of the sheath wall, adjacent the sheath lumen, or an outer surface of the sheath wall;

inserting at least the distal end of the sheath into a bodily tissue or a bodily orifice or cavity;

receiving a portion of a medical device within at least a portion of the sheath lumen;

coupling an illumination assembly to the sheath proximal end, the illumination assembly comprising a housing, including a housing chamber and a housing lumen, and a sterilizing light source electrically coupled to a battery and disposed within the housing chamber, wherein the housing lumen is collinear with the sheath lumen when the housing illumination assembly is coupled to the sheath proximal end; and

transmitting a sterilizing light from the sterilizing light source through the sheath wall in a direction substantially normal to the wall.

12. The method of claim 11, wherein the step of receiving includes advancing the medical device through the sheath lumen to the sheath distal end and into a bodily tissue or into a bodily orifice or cavity.

13. A sterilization system, comprising:

a cylindrical sheath, extending from a sheath proximal end to a sheath distal end, including a sheath wall configured to receive and transmit a sterilizing light and defining a sheath lumen, the sheath wall including at least one channel comprising a longitudinal portion and a transverse portion, extending in a direction transverse to the longitudinal portion, the transverse portion including a port formed in an inner surface of the sheath wall, adjacent the sheath lumen, or an outer surface of the sheath wall; and

an integrated, stand-alone illumination assembly configured to be removably coupled to the sheath proximal end, the illumination assembly comprising;

a housing, including a housing chamber and a housing lumen; and

a sterilizing light source electrically coupled to a battery and disposed within the housing chamber, the housing lumen configured to be collinear with the sheath lumen when the housing illumination assembly is coupled to the sheath proximal end.

14. The system of claim 13, the sheath wall including at least one channel formed within the sheath wall, the at least one channel including air, a light conductive polymer, a light conductive gas, or a light conductive liquid.

15. The system of claim 13, wherein the sheath wall comprises an outer surface and an inner surface, at least one of the outer surface and inner surface includes a raised or embossed pattern formed therein to disperse light in a dispersion pattern corresponding to the raised or embossed pattern.

16. The system of claim 13, wherein the sheath wall includes an outer surface and an inner surface, a plurality of pores are formed in at least one of the outer surface or the inner surface, the plurality of pores configured to circumferentially disperse light.

17. The system of claim 13, wherein the sterilizing light source comprises a plurality of lamps configured to emit a sterilizing light.